Events

Retiro De Equipo (Recall) de Device Recall CystoCare Coloplast

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Nurse Assist, Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    58021
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2285-2011
  • Fecha de inicio del evento
    2011-01-20
  • Fecha de publicación del evento
    2011-05-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-10-25
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98820
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, urological - Product Code KOD
  • Causa
    The trays contain triad group sterile lubricating jelly packs recalled by triad group because of the possibility of inadequate sterilization.
  • Acción
    The firm, Nurse Assist Incorporated, sent a letter dated January 20, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory immediately; quarantine the product; identify their customers and notify them at once about the product recall (Nurse Assist will provide bright labels to affix to your affected inventory); provide their customers with labels as well, and complete and return the attached RECALL ACKNOWLEGEMENT form via fax to: 817-231-1500 or mail to: Nurse Assist, Inc., 3400 Northern Cross Blvd., Forth Worth, TX 76137. Only the product and lots identified on the attached list are affected. If you have any questions or to request labels, please call Nurse Assist Customer Service Monday through Friday, from 8:00 am to 5:00 pm Central Time at 1-800-649-6800.

Device

Device Recall CystoCare Coloplast
  • Modelo / Serial
    Lot Codes: 1003280, 1004332, 1007366, 1009096, 1010239, 806072, 807115, 809070, 810232, 904045, 908150, 909325, 910225, 1001033, 1001124, 1001326, 1002032, 1002194, 1002264, 1002349, 1003051, 1003162, 1003277, 1003336, 1003342, 1004240, 1004327, 1005003, 1005178, 1005320, 1006192, 1006317, 1007023, 1007364, 1007372, 1008021, 1008197, 1008270, 1009019, 1009072, 1009095, 1009177, 1009281, 1009385, 1010124, 1010208, 1010238, 1010378, 1011078, 1011116, 1011241, 1011338, 806073, 806123, 806207, 806276, 807116, 807156, 809066, 809279, 811068, 811136, 812043, 812217, 901129, 901208, 901258, 902049, 902227, 902313, 903069, 903162, 903223, 903329, 904352, 905075, 905181, 906036, 906319, 906324, 907175, 907226, 907411, 908148, 908345, 909172, 909268, 909323, 910004, 910219, 910316, 911073, 912152, 912243, and 912359.
  • Clasificación del producto
    Gastroenterology-Urology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • Descripción del producto
    Case Label: REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Manufactured for: Coloplast A/S 3050 Denmark || Tray Label: Cysto-Care Coloplast REF: UT7030 Catheter Insertion Tray 30 cc Pre-Filled Syringe with PVP Swabs Contents 1200 cc graduated drainage tray Waterproof underpad Fenestrated drape Vinyl gloves (2) cuffed Lubricating jelly Specimen container with ID label 30 cc pre-filled syringe Swabsticks (3) PVP solution For Rx Only. Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA || Intended use: The trays are urological catheter trays.
  • Manufacturer
    Nurse Assist, Inc

Manufacturer

Nurse Assist, Inc
  • Dirección del fabricante
    Nurse Assist, Inc, 3400 Northern Cross Blvd, Fort Worth TX 76137-3600
  • Empresa matriz del fabricante (2017)
    Nurse Assist Inc.
  • Source
    USFDA